Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

U

University of Missouri (MU)

Status

Withdrawn

Conditions

Tympanic Membrane Perforation

Treatments

Other: Fascia
Other: Skye Barrier

Study type

Interventional

Funder types

Other

Identifiers

NCT03028272
2006074

Details and patient eligibility

About

The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Full description

A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Presence of a tympanic membrane perforation
  • Patient at PI's clinic

Exclusion criteria

  • Presence of cholesteatoma
  • Prior surgery on the same-sided TM or middle ear
  • Ossicular chain abnormalities
  • Congenital deformities involving the middle ear or eustachian tube
  • Refusal to undergo surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Fascia
Active Comparator group
Description:
Autologous donor substrate
Treatment:
Other: Fascia
Skye Barrier
Experimental group
Description:
Amniotic membrane allograft
Treatment:
Other: Skye Barrier

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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